Rapid Renal Sympathetic Denervation for Resistant Hypertension

NCT01520506 | Completed Results

• 1 other identifier: CIP 012
• Study Type: interventional
• Target: 50
• Locations: 6 countries
• Sites: 14

Brief Summary

The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Conditions

Hypertension, Resistant to Conventional Therapy

Keywords

Hypertension; Kidney Diseases; Kidney Failure, Chronic; Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Acute Procedural Safety

  Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge: * SAE's related to groin and vascular access complications, and * SAE's related to renal artery injury.

  One Week

Secondary Outcomes (2)

• Chronic Procedural Safety

  6 months

• Renal Denervation Procedure Effectiveness

  From baseline to 6 months

Study Arms (1)

Rapid Renal Denervation

EXPERIMENTAL

Device: Covidien OneShot™ System

Interventions

Covidien OneShot™ System DEVICE

Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.

Also known as: Covidien OneShot™ Renal Denervation System

Rapid Renal Denervation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
• Age 18-85 years.
• Able to provide informed consent and comply with follow-up visits.

You may not qualify if:

• Diameter of left or right renal artery less than 4 mm or greater than 7mm.
• Length of target segment of left or right renal artery less than 20mm.
• Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
• End-stage renal disease requiring dialysis or renal transplant.
• estimated Glomerular Filtration Rate \< 45 mL/min per 1.73 m2.
• Type 1 diabetes mellitus.
• Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
• Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.
• Bleeding disorder or refusing blood transfusions.
• Pregnancy or breast feeding.
• Peripheral vascular disease precluding catheter insertion.
• Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
• Current enrollment in another investigational drug or device Study.

Sponsors & Collaborators

• Medtronic Endovascular: lead
• Medtronic - MITG: collaborator
• Meditrial Europe Ltd.: collaborator

Study Sites (14)

Middelheim Hospital

Antwerp, Belgium

Location

Ziekenhuis Oost--Limburg

Genk, 3600, Belgium

Location

Universitatklinikum

Bonn, Germany

Location

Cardiovascular Center Sankt Katharinen

Frankfurt, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Univ. Medical Klinik III

Heidelberg, Germany

Location

Franziskus Hospital

Münster, Germany

Location

Hospital San Raffaele

Milan, Italy

Location

Centre Hospitalier De Luxembourg

Luxembourg, L-1210, Luxembourg

Location

Santa Catharina Hospital

Eindhoven, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus MC Thoraxcenter

Rotterdam, Netherlands

Location

UMC Universitair Medisch Centrum

Utrecht, Netherlands

Location

Mercy Angiography Unit

Auckland, New Zealand

Location

Related Publications (1)

• Verheye S, Ormiston J, Bergmann MW, Sievert H, Schwindt A, Werner N, Vogel B, Colombo A. Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study. EuroIntervention. 2015 Feb;10(10):1221-9. doi: 10.4244/EIJY14M12_02.

  PMID: 25452198 DERIVED

Related Links

• Covidien (manufacturer)

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy; Hypertension; Kidney Diseases; Kidney Failure, Chronic; Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Cihlar
• Organization: Medtronic

stephanie.a.cihlar@medtronic.com

763-398-7932

Study Officials

• W.A.L. Tonino, MD

  Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands

  PRINCIPAL INVESTIGATOR

• Stefan Verheye, MD

  Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: January 30, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: June 1, 2014
• Last Updated: March 1, 2019
• Results First Posted: September 16, 2015

Record last verified: 2019-02

Locations

DE (5); BE (2); NZ (1); LU (1); NL (4); IT (1)